LC MEDICAL CONCEPTS

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Negative Pressure Wound Therapy Powered Suction Pump (OMP) (5) Dressing, Wound, Hydrophilic (NAC) (1)

Premarket Exempt

No Yes

Clear

Dressing, Wound, Hydrophilic - B530LCW151010 Catalog Number :

Device Description : White Hydrophilic Foam Dressing

Device Class : 1

Duns Number: 093992526

Premarket Exempt : Yes

Product Code : NAC

Prescription Use : No

Device Count : 1

Negative Pressure Wound Therapy System Foam Dressing - B530UDP130 Catalog Number : UDP13

Device Description : NPWT Suction Dome Pad connection tube and ported pad

Device Class : 2

Duns Number: 093992526

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Negative Pressure Wound Therapy System Foam Dressing - B530UN1083S0 Catalog Number : UN1083S

Device Description : Small Black Foam Negative Pressure Wound Therapy Dressing Kit

Device Class :

Duns Number: 093992526

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Negative Pressure Wound Therapy System Foam Dressing - B530UN20133M0 Catalog Number :

Device Description : Medium Black Foam Negative Pressure Wound Therapy Dressing Kit

Device Class :

Duns Number: 093992526

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Negative Pressure Wound Therapy System Foam Dressing - B530UN25163L0 Catalog Number :

Device Description : Large Black Foam Negative Pressure Wound Therapy Dressing Kit

Device Class : 2

Duns Number: 093992526

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

Negative Pressure Wound Therapy System Foam Dressing - B530UTD250 Catalog Number : UTD24

Device Description : NPWT Ported Dome pad

Device Class : 2

Duns Number: 093992526

Premarket Exempt : No

Product Code : OMP

Prescription Use : Yes

Device Count : 1

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